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FDA 510(k)

PITT-EASY DENTAL IMPLANT SYSTEM

K-Number: K083297 · 2009-01-28

ApplicantSybron Implant Solutions GmbH
Decision Date2009-01-28
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PITT-EASY DENTAL IMPLANT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Sybron Implant Solutions GmbH. It received FDA 510(k) clearance on 2009-01-28 under 510(k) number K083297. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PITT-EASY DENTAL IMPLANT SYSTEM?

PITT-EASY DENTAL IMPLANT SYSTEM is a medical device that received FDA 510(k) clearance on 2009-01-28. The listed applicant is Sybron Implant Solutions GmbH. The 510(k) number is K083297.

When did PITT-EASY DENTAL IMPLANT SYSTEM receive FDA 510(k) clearance?

PITT-EASY DENTAL IMPLANT SYSTEM received FDA 510(k) clearance on 2009-01-28, under 510(k) number K083297.

Who is the listed applicant for PITT-EASY DENTAL IMPLANT SYSTEM?

The FDA 510(k) record lists Sybron Implant Solutions GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PITT-EASY DENTAL IMPLANT SYSTEM?

The FDA product code for PITT-EASY DENTAL IMPLANT SYSTEM is DZE.

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Related Devices (Code: DZE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261392TriActive Dental Implant SystemParagon Implant Mfg., LLCK260463ZEROS Dental Implant SystemZeros Co., Ltd.K251188UNIQA® Dental Implants SystemUniqa Dental, Ltd.K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd.K250806Dental Implant SystemA.B. Dental Devices , Ltd.K260006INOSS SystemInosys, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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